Download details - Global Pharmaceuticals Pakistan

Gutt
1 mg Tablets
1
)
)
(Cinitapride)
COMPOSITION
Each tablet contains:
Cinitapride as Hydrogen Tartrate ........ 1 mg
PHARMACOLOGY
GUTT contains cinitapride hydrogen tartrate which is a new prokinetic agent. It is a substituted benzamide with 5-HT
receptor antagonist and agonist activity.
PHARMACOKINETICS
The absorption of cinitapride (12mg) following oral administration was rapid, with peak levels being achieved 2 h after
dosing; absorption following intramuscular administration (4mg) was even more rapid, with peak levels (50% more than
oral levels) being achieved 1 h after dosing. The elimination profile in man was similar by either route of administration,
with a half life of some 3-5 h during the first 8 h and a residual half-life greater than 15 h thereafter. Since the urinary 24-h
excretion of cinitapride and its two major metabolites (principally the de-alkylated product) was no greater than 7% of
the administered dose, this is obviously only a minor elimination pathway.
INDICATION
GUTT is indicated for the treatment of gastrointestinal disorders associated with motility disturbances such as
gastroesophageal reflux disease, non-ulcer dyspepsia and delayed gastric emptying.
DOSAGE AND ADMINISTRATION
The usual daily dosage for adults is 1mg of Gutt orally thrice a day 15 minutes before meals. The dose may be reduced,
if required, depending on the patient's age and symptoms at the discretion of the physician.
CONTRAINDICATIONS
GUTT is contraindicated in patients with known hypersensitivity to Cinitapride or any of the other constituents of the
formulation.
WARNINGS AND PRECAUTIONS
GUTT should be used with caution especially in the elderly because it enhances the action of acetylcholine. It should
not be used in patients in whom an increase in gastrointestinal motility could be harmful, e.g. in patients with
gastrointestinal hemorrhage, mechanical obstruction or perforation. GUTT should be used with caution in patients with
a history of dyskinesia induced by neuroleptics. Drowsiness may occur with the use of cinitapride and hence caution is
to be exercised while driving and using machines. This drug should not be taken with alcohol since increased sedation
may occur.
DRUG INTERACTIONS
Anticholinergic agents like atropine, Scopolamine etc, may reduce the action of cinitapride. Cinitapride can enhance
the effect of medicines that are used for the treatment of illnesses of the nervous system and for insomnia. Cinitapride
can also alter the absorption of some medicines e.g. digoxin as it simulates gastric emptying.
Pregnancy
The safety of this product in pregnant women has not been established. Cinitapride should only be used in pregnant
women if the expected benefits outweigh the possible risk.
Lactation
Treatment with cinitapride should be avoided during lactation.
Pediatrics
The safety of this product has not been established in children.
UNDESIRABLE EFFECTS
Cinitapride has usually been very well tolerated with the most common adverse events in clinical trials being
drowsiness and diarrhea. Extrapyramidal effects (involuntary muscular movements of the head, neck and tongue)
have been reported occasionally. Very rarely, cutaneous reactions like eruptions, itching or angioedema and
gynecomastia have been reported.
OVERDOSAGE
There have as yet been no reports of overdose in humans. The symptoms of overdose include drowsiness, confusion
and extrapyramidal effects. Cinitapride hydrogen tartrate does not cause QT prolongation. In case of excessive
overdosage, the usual measures of gastric lavage and symptomatic therapy should be applied. The extrapyramidal
effects should be treated with antiparkinsonians, anticholinergics or antihistaminics with anticholinergic properties.
PRESENTATION:
A pack of 10 Tablets.
2008
Global Pharmaceuticals (Pvt) Ltd.
Plot No. 204 - 205, Industrial Triangle,
Kahuta Road, Islamabad - Pakistan.